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FDA Approval

Pilocarpine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Effective Date

September 22, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pilocarpine(40 mg in 1 mL)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pilocarpine Hydrochloride

Product Details

NDC Product Code

60219-1747

Application Number

ANDA214193

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

September 22, 2020

Ingredients

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 40 mg in 1 mL

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

HYPROMELLOSE 2910 (10000 MPA.S)Inactive

Code: 0HO1H52958Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code

60219-1746

Application Number

ANDA214193

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

September 22, 2020

Ingredients

HYPROMELLOSE 2910 (10000 MPA.S)Inactive

Code: 0HO1H52958Class: IACT

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 20 mg in 1 mL

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Pilocarpine Hydrochloride

Product Details

NDC Product Code

60219-1745

Application Number

ANDA214193

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

September 22, 2020

Ingredients

PilocarpineActive

Code: 0WW6D218XJClass: ACTIBQuantity: 10 mg in 1 mL

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

HYPROMELLOSE 2910 (10000 MPA.S)Inactive

Code: 0HO1H52958Class: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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Pilocarpine Hydrochloride - FDA Approval | MedPath